Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -

NCT00444093 | Terminated Phase 3 DMC

• 2 other identifiers: 2006-002948-28KKS-73-05
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.

Conditions

Diarrhea; Enteritis; Cancer

Keywords

radiation therapy; diarrhea; enteritis; supportive therapy; therapy associated diarrhea; therapy associated enteritis; radiation therapy of the small pelvis

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy

  In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade \> 2 is successfully averted during (cancer) therapy.

  90 days

Secondary Outcomes (2)

• Quality of life EORTC-QLQ C30

  90 days

• Diarrhea Assessment

  90 days

Study Arms (2)

Opii normata treatment

EXPERIMENTAL

Treamtment with opii normata in case of diarrhea

Drug: Opii normata treatment

Loperamid Treatment

EXPERIMENTAL

Treatment with Loperamid in case of diarrhea

Drug: Loperamid Treatment

Interventions

Opii normata treatment DRUG

After beginning of diarrhea grade 1: 5 drops tincture of opium three times a day After beginning of diarrhea grade 2: Intensive therapy with 15 drops tincture of opium three times a day.

Opii normata treatment

Loperamid Treatment DRUG

All patients who receive as a result of randomisation loperamide After beginning of diarrhea grade 1: Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day. After beginning of diarrhea grade 2: Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day.

Loperamid Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma.
• Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0)
• ECOG-Grade 0-2
• Enlightenment and written declaration of consent to the participation.

You may not qualify if:

• Pregnant patients or patients in lactation period.
• Severe dysfunction of liver or kidneys
• Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis
• Epilepsy
• Hypersensitivity to components of loperamide or tincture of opium
• Ileus
• Toxic megacolon
• Pseudomembranous colitis/ antibiotic-associated colitis
• Diarrhea associated with fever and bloody stools
• Acute increase of colitis ulcerous or bacterial colitis caused by invasive pathogenes
• Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis
• Dysfunctional draining of biliary area, biliary colics.
• Concomitant or earlier addiction of alcohol or opiates
• Severe heart disease
• Pheochromocytoma

Sponsors & Collaborators

• Philipps University Marburg: lead
• Maros Arznei GmbH: collaborator

MeSH Terms

Conditions

Diarrhea; Enteritis; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Michael Bieker, MD

  center of radiology, departement of radiation therapy, clinical center Giessen and Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: March 5, 2007
• Primary Completion: February 29, 2008
• Study Completion: February 29, 2008
• Last Updated: May 11, 2023

Record last verified: 2018-04